Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure

Abstract

Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure Hampton, J.R.; Veldhuisen, D.J.; Kleber, F.X.; Cowley, A.J.; Ardia, A.; Block, P.; Cortina, A.; Cserhalmi, L.; Follath, F.; Jensen, G.; Kayanakis, J.; Lie, K.I.; Mancia, G.; Skene, A.M. Published in: Lancet DOI:10.1016/S0140-6736(96)10488-8 Link to publicationCitation for published version (APA): Hampton, J. R., Veldhuisen, D. J., Kleber, F. X., Cowley, A. J., Ardia, A., Block, P., ... Skene, A. M. (1997). Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure. Lancet, 349, 971-977. https://doi.org/10.1016/S0140-6736(96)10488-8 General rightsIt is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulationsIf you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: http://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. Download date: 22 Mar 2019Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure J R Hampton, D J van Veldhuisen, F X Kleber, A J Cowley, A Ardia, P Block, A Cortina, L Cserhalmi, F Follath, G Jensen, J Kayanakis, K I Lie, G Mancia, A M Skene, for the Second Prospective Randomised Study of Ibopamine on Mortality and Efficacy (PRIME II) Investigators THE LANCET SummaryBackground Drugs that improve symptoms in patients with heart failure must also be assessed for their effects on survival. Ibopamine stimulates DA-1 and DA-2 receptors and causes peripheral and renal vasodilatation; the drug improves symptoms of heart failure. W e assessed the effect of ibopamine on survival in patients with advanced heart failure in a mult ic ent re, randomised plac ebocontrolled study.

The evolution of the randomized controlled trial and its role in evidence‐based decision making

“…RCT was stopped early after 1906 patients were enrolled, because of a 28% relative increase in mortality with ibopamine compared with placebo [17]. A physiological study demonstrated beta-blockers result in a decline in ejection fraction and increases in end-diastolic volume in patients with prior myocardial infarction [18].…”

Insuficiência cardíaca

“…Parece ser uma resposta de grupo, pois estudos com dopamina, dobutamina, anrinone, miorinone, vesnarinone, ibopamina etc. mostraram aumento de mortalidade 5,[50][51][52][53][54] .…”

Em busca de novos paradigmas para o manejo da insuficiência cardíaca

“…A despeito da melhora hemodinâmica e aumento da capacidade funcional [9][10][11][12][13] , a administração crônica desses agentes resultou, invariavelmente, em aumento da mortalidade [14][15][16][17][18] . Cabe ressaltar, por exemplo, o estudo PROMISE, que avaliou o uso de milrinone, um inibidor da fosfodiesterase por via oral, em mais de 1000 pacientes com IC classe funcional (CF) III e IV, e demonstrou um aumento de 28% na taxa de mortalidade no grupo de pacientes em uso da droga, quando comparados ao grupo que recebeu placebo 15 .…”

“…Cabe ressaltar, por exemplo, o estudo PROMISE, que avaliou o uso de milrinone, um inibidor da fosfodiesterase por via oral, em mais de 1000 pacientes com IC classe funcional (CF) III e IV, e demonstrou um aumento de 28% na taxa de mortalidade no grupo de pacientes em uso da droga, quando comparados ao grupo que recebeu placebo 15 . Mais recentemente, o ensaio PRIME II avaliou a administração do agonista dopaminérgico de uso oral, ibopamina, comparado ao uso de placebo 14 . Esse ensaio foi suspenso pelo comitê de monitorização de segurança por aumento de mortalidade no grupo que recebeu a droga.…”